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FDA 510(k)

IMMUNODOT RUBELLA TEST

K-Number: K894546 · 1989-10-16

ApplicantGeneral Biometrics, Inc.
Decision Date1989-10-16
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNODOT RUBELLA TEST is the device name listed in this FDA 510(k) record. The listed applicant is General Biometrics, Inc.. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K894546. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNODOT RUBELLA TEST?

IMMUNODOT RUBELLA TEST is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is General Biometrics, Inc.. The 510(k) number is K894546.

When did IMMUNODOT RUBELLA TEST receive FDA 510(k) clearance?

IMMUNODOT RUBELLA TEST received FDA 510(k) clearance on 1989-10-16, under 510(k) number K894546.

Who is the listed applicant for IMMUNODOT RUBELLA TEST?

The FDA 510(k) record lists General Biometrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNODOT RUBELLA TEST?

The FDA product code for IMMUNODOT RUBELLA TEST is LFX.

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Other records listing General Biometrics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELK920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTK920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTK911627IMMUNODOT BORRELIA (LYME) TESTK911599IMMUNOWELL LYME (P39 RECOMBINANT) TESTK911590IMMUNOWELL BORRELIA (LYME)TEST

View all 23 devices →

Related Devices (Code: LFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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